Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients

Ketamine

Brief Summary

Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.

Intervention / Treatment

  • Ketamine (DRUG)
    Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
  • Placebo (DRUG)
    Patients who received ketamine-matching placebo were given saline infusions
  • Hydromorphone PCA (DRUG)
    Intravenous hydromorphone PCA

Condition or Disease

  • Postoperative Pain

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years and older   (Adult, Older Adult)
    Enrollment: 64 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2008
    Primary Completion: Jun 01, 2011 ACTUAL
    Completion Date: Jun 01, 2012 ACTUAL
    Study First Posted: May 04, 2012 ESTIMATED
    Results First Posted: Mar 22, 2017 ACTUAL
    Last Updated: Feb 01, 2017

    Sponsors / Collaborators

    Lead Sponsor: Brigham and Women's Hospital
    Responsible Party: N/A

    Location

    Boston, Massachusetts, USA

    Participant Groups

    • Participants received postoperative hydromorphone patient-controlled analgesia (PCA) and continuous ketamine (0.2 mg/kg/hour). Ketamine is being compared to the use of placebo, in addition to intravenous opioids, for postop pain control in opioid dependent patients who undergo major surgery.

    • Participants received postoperative hydromorphone PCA and continuous ketamine-matching placebo (infusion of saline).

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Chronic pain \> 6 months
    * Long term use of opioids
    * Major surgery

    Exclusion Criteria:

    * Use of regional anesthetic techniques
    * No need for intravenous (IV) patient controlled analgesia (PCA) after surgery

    Primary Outcomes

    • Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.

    Secondary Outcomes

    • Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average worst postoperative pain score for each treatment arm is reported.

    • Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average least postoperative pain score for each treatment arm is reported.

    • Opioid use is defined as the total milligrams of hydromorphone plus other home or oral opioid used per 24 hours, converted to oral morphine equivalents.

    • Participants were asked to complete a "Side Effects Checklist" to assess for any unwanted side effects (AEs) of drugs that were administered. The determination of whether or not an AE was treatment related was at the discretion of the Investigator.

    More Details

    NCT Number: NCT01591382
    Other IDs: 2008P001126
    Study URL: https://clinicaltrials.gov/study/NCT01591382
    Last updated: Sep 29, 2023